Biosimilar Remedies Not Limited Without Full Patent Dance

The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar remedies would not be limited to a reasonable royalty under 35 USC § 271(e)(6) if it turns out that Janssen lacks standing for failure to join all owners of the patents-in-suit, and must file a new suit. He announced his guidance at hearings on February 23-24, and in a written Memorandum and Order issued March 2. Continue reading this entry

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. Perhaps more importantly, the clock still may be running against Genentech to make the next move in the patent dance. Continue reading this entry

PTAB Puts Method Of Treatment Patents Under The 101 Knife

While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine. However, several decisions from the USPTO Patent Trial and Appeal Board (PTAB) have found personalized method of treatment claims ineligible under Mayo. Did the Supreme Court really intend to put such methods under the 35 U.S.C. § 101 knife? Continue reading this entry

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA’s information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen’s Abbreviated Biologic License Application (aBLA). This case is not the first to highlight the difficulties with a statutory scheme that requires fierce competitors to share highly confidential information, but may lead to the first decision on just how much information a biosimilar applicant has to disclose and to whom. Continue reading this entry

Federal Circuit Finds "Consisting Of" Requires Reversing Infringement Of Shire Lialda Patent

The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so doing, the court emphasized the narrow scope of the Norian exception to the “closed” nature of “consisting of” language that applies only for “aspects unrelated to the invention.”

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